Contamination Control - HACCP Expert

The Contamination Control Risk Management Specialist is responsible for developing, implementing, maintaining, and continuously improving contamination control risk management programs across pharmaceutical, biotechnology, aseptic manufacturing, and medical device operations. The role focuses on application of Hazard Analysis and Critical Control Points (HACCP), contamination control strategies (CCS), particulate matter risk assessments, and Annex 1 compliance to ensure product quality, patient safety, and regulatory compliance.

This position serves as the subject matter expert for contamination hazards, particulate contamination risks, aseptic process risks, and contamination control effectiveness throughout the product lifecycle.

Key Responsibilities

Contamination Control Risk Management

Lead contamination control risk assessments utilizing HACCP, Risk Analysis, PFMEA, and Hazard Analysis methodologies.
Develop and maintain site-wide Contamination Control Strategies (CCS) in alignment with EU GMP Annex 1 requirements.
Identify and evaluate contamination hazards including:
Viable contamination
Non-viable particulate contamination
Cross-contamination
Personnel contamination
Utility-related contamination
Environmental contamination
Raw material contamination
Establish risk-based contamination control measures and monitoring strategies.
Facilitate multidisciplinary risk assessment workshops.
HACCP Program Management

Develop and maintain HACCP plans for aseptic and non-aseptic manufacturing processes.
Conduct hazard identification and critical control point (CCP) determination.
Define:
Critical limits
Monitoring requirements
Corrective actions
Verification activities
Ensure HACCP documentation remains current and inspection-ready.
Support regulatory inspections and audits related to contamination control.
Particulate Matter Risk Management

Lead particulate contamination risk assessments across facilities, equipment, processes, and products.
Evaluate particulate generation sources including:
Personnel activities
Equipment wear
Packaging materials
Single-use systems
HVAC systems
Cleaning activities
Manufacturing processes
Perform risk evaluations for:
Visible particles
Sub-visible particles
Environmental particulate contamination
Develop mitigation strategies to reduce particulate contamination risks.
Support investigations involving particulate excursions and contamination events.
Environmental Monitoring & Trending
Integrate contamination control risk assessments with:
PFMEA
Hazard Analysis
Process Risk Assessments
Change Controls
Deviations
CAPA Programs
Ensure contamination risks are reflected within overall quality risk management processes.
Support lifecycle contamination risk management activities.
Investigations & Remediation

Lead root cause investigations for contamination events.
Conduct impact assessments for:
Environmental excursions
Sterility failures
Microbial contamination
Particulate contamination findings
Develop and track CAPAs related to contamination control deficiencies.
Verify effectiveness of implemented corrective actions.
Regulatory Compliance

Ensure compliance with:
EU GMP Annex 1
ICH Q9 Quality Risk Management
ISO 14971 (where applicable)
PDA Technical Reports
USP <788>, <789>, and applicable particulate requirements
FDA aseptic processing guidance
ISO 14644 cleanroom standards
Support inspections by FDA, EMA, MHRA, and notified bodies.
Required Qualifications

Education

Bachelor's degree in:
Microbiology
Pharmaceutical Sciences
Biotechnology
Engineering
Quality Assurance
Related scientific discipline
Experience

5+ years of experience in contamination control, quality risk management, microbiology, aseptic processing, or quality assurance.
Experience conducting HACCP risk assessments.
Experience developing contamination control strategies.
Experience investigating contamination and particulate matter events.
Technical Knowledge


Pay: $30.00 - $45.00 per hour

Work Location: Remote